Type 2 DiabetesLIFT-DMNCT04181424
Lowering the Impact of Food Insecurity in African American Adults With Type 2 Diabetes Mellitus (LIFT-DM)
A study testing Diabetes Education Plus Monthly Food Vouchers, Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes and Diabetes Education Only in people with Type 2 Diabetes, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The objective of this protocol is to answer the questions: 1) Within food supplementation options, are mailed stock boxes superior to food vouchers in terms of achieving glycemic control? 2) Is the combination of mailed stock boxes and food vouchers superior to either food supplementation option alone? 3) Does… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Diabetes Education Plus Monthly Food Vouchers, Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes and Diabetes Education Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2019to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: 1) age >=21 years; 2) self-report as African American/non-Hispanic Black; 3) screen positive for food insecurity over past 12-months using screening questionnaire; 4) clinical diagnosis of type 2 diabetes and HbA1c >=8% at the screening visit; 5) income <=133% of federal poverty level based on household income and size of household or Medicaid eligible; 6) able to communicate in English.
Exclusion Criteria: 1) Mental confusion on interview suggesting significant dementia; 2) Participation in other diabetes clinical trials; 3) Alcohol or drug abuse/dependency; 4) Active psychosis or acute mental disorder; and 5) Life expectancy <12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York at Buffalo
Buffalo, New York, 14203
About this study
The objective of this protocol is to answer the questions: 1) Within food supplementation options, are mailed stock boxes superior to food vouchers in terms of achieving glycemic control? 2) Is the combination of mailed stock boxes and food vouchers superior to either food supplementation option alone? 3) Does providing diabetes education in combination with food supplementation lead to improved clinical outcomes compared to education alone? To address this gap in the literature, we propose a randomized controlled trial to test the separate and combined efficacy of monthly food vouchers to farmers market and monthly mailed food stock boxes layered upon diabetes education in improving glycemic control in low income, food insecure, AAs with Type 2 Diabetes (T2DM) using a 2x2 factorial design.
Read the detailed description
The overarching aim of this proposal is to conduct a 4-arm RCT to test the separate and combined efficacy of monthly food vouchers to farmers market and monthly mailed food stock boxes layered upon diabetes education in improving glycemic control in low income, food insecure, AAs with T2DM using a 2x2 factorial design. 300 patients will be randomly assigned to four groups of 75 patients each: 1) diabetes education alone; 2) diabetes education plus food vouchers; 3) diabetes education plus mailed stock boxes; and 4) diabetes education plus combined food vouchers and mailed stock boxes. Each patient will be followed for 12 months, with study assessments at baseline, 3, 6, and 12 months. Primary aim is efficacy of separate and combined interventions on HbA1c at 12 months post-randomization. Secondary aims are efficacy of separate and combined interventions on BP, LDL and QOL as well as cost-effectiveness at 12 months post-randomization.
Description of the LIFT-DM Intervention Group 1 - Diabetes Education Only: Individuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation. Twelve 30-minute weekly sessions will be delivered via the telephone, with two 30-minute booster sessions at months 6 and 9.
Group 2 - Diabetes Education Plus Monthly Food Vouchers: Individuals assigned to this group will receive diabetes education and skills training and monthly food vouchers for use at local farmer's markets mailed to their home. Vouchers for $50 will be mailed monthly for 12 months.
Group 3 - Diabetes Education Plus Monthly Stock Boxes: Individuals assigned to this group will receive diabetes education and skills training and monthly stock boxes with diabetes appropriate food items mailed to their home. Stock boxes with foods valued at $50 will be mailed monthly for 12 months.
Group 4 - Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes: Individuals assigned to this group will receive diabetes education and skills training, monthly food vouchers for use at local farmer's markets mailed to their home, and monthly stock boxes with diabetes appropriate food items mailed to their home. Vouchers for $25 and stock boxes with food valued at $25 will be mailed monthly for 12 months. In essence, the combined group will still receive $50 worth of food supplementation monthly as combination of $25 vouchers and $25 mailed stock boxes.
- Conditions
- Type 2 Diabetes
- Being tested
- Diabetes Education Plus Monthly Food Vouchers, Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes, Diabetes Education Only, Diabetes Education Plus Monthly Stock Boxes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Education Plus Monthly Food VouchersBehavioural
Individuals assigned to this group will receive diabetes education and skills training and monthly food vouchers for use at local Farmer's markets mailed to their home.
Diabetes Education Plus Combination of Monthly Food Vouchers and Stock BoxesBehavioural
Individuals assigned to this group will receive diabetes education and skills training, monthly food vouchers for use at local Farmer's markets mailed to their home, and monthly stock boxes with diabetes appropriate food items mailed to their home.
Diabetes Education OnlyBehavioural
Individuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation.
Diabetes Education Plus Monthly Stock BoxesBehavioural
Individuals assigned to this group will receive diabetes education and skills training and monthly stock boxes with diabetes appropriate food items mailed to their home.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- Diabetes Education Only | Active comparator | Individuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation. Receives: Behavioral: Diabetes Education Only |
| Group 2 - Diabetes Education Plus Monthly Food Vouchers | Experimental | Individuals assigned to this group will receive diabetes education and skills training and monthly food vouchers for use at local Farmer's markets mailed to their home. Receives: Behavioral: Diabetes Education Plus Monthly Food Vouchers |
| Group 3 - Diabetes Education Plus Monthly Stock Boxes | Experimental | Individuals assigned to this group will receive diabetes education and skills training and monthly stock boxes with diabetes appropriate food items mailed to their home. Receives: Behavioral: Diabetes Education Plus Monthly Stock Boxes |
| Group 4 -- Diabetes Education Plus Combination of Monthly Food | Experimental | Individuals assigned to this group will receive diabetes education and skills training, monthly food vouchers for use at local Farmer's markets mailed to their home, and monthly stock boxes with diabetes appropriate food items mailed to their home. Receives: Behavioral: Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control (HbA1c)
Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.
Measured: 12-months post randomization
Secondary outcomes (3)
Quality of Life as measured by the SF-12
The SF-12 (Ware 1996) is a valid and reliable instrument to measure functional status and reproduces 90% of the variance in PCS-36 and MCS-36 scores.
Measured: 12-months post randomization
LDL-Cholesterol
About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for LDL-Cholesterol.
Measured: 12-months post randomization
Blood Pressure
Blood pressure readings will be obtained using automated BP monitors (OMRON IntelliSenseTM HEM-907XL). The device will be programmed to take 3 readings at 2-minute intervals, and give an average of the 3 BP readings.
Measured: 12-months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start15 Dec 2019
- Primary completion30 Jun 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonard Ehianu Egede, State University of New York at Buffalo
- Investigators
- Leonard E Egede, MD, Principal investigator, State University of New York at BuffaloRebekah J Walker, PhD, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181424
- Sponsor's protocol ID
- 5R01MD013826
- Acronym
- LIFT-DM
- Status last verified
- Oct 2026
- First submitted
- 26 Nov 2019
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Walker RJ, Knapp RG, Dismuke-Greer CE, Walker RE, Ozieh MN, Egede LE. Lowering the impact of food insecurity in African American adults with type 2 diabetes mellitus (LIFT-DM) - Study protocol for a randomized controlled trial. Contemp Clin Trials. 2020 Dec;99:106206. doi: 10.1016/j.cct.2020.106206. Epub 2020 Nov 7.
PubMed 33166622
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lowering the Impact of Food Insecurity in African American Adults With Type 2 Diabetes Mellitus (LIFT-DM)
- ClinicalTrials.gov ID
- NCT04181424
- Acronym / sponsor ID
- LIFT-DM / 5R01MD013826
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this protocol is to answer the questions: 1) Within food supplementation options, are mailed stock boxes superior to food vouchers in terms of achieving glycemic control? 2) Is the combination of mailed stock boxes and food vouchers superior to either food supplementation option alone? 3) Does providing diabetes education in combination with food supplementation lead to improved clinical outcomes compared to education alone? To address this gap in the literature, we propose a randomized controlled trial to test the separate and combined efficacy of monthly food vouchers to farmers market and monthly mailed food stock boxes layered upon diabetes education in improving glycemic control in low income, food insecure, AAs with Type 2 Diabetes (T2DM) using a 2x2 factorial design.
Detailed description
The overarching aim of this proposal is to conduct a 4-arm RCT to test the separate and combined efficacy of monthly food vouchers to farmers market and monthly mailed food stock boxes layered upon diabetes education in improving glycemic control in low income, food insecure, AAs with T2DM using a 2x2 factorial design. 300 patients will be randomly assigned to four groups of 75 patients each: 1) diabetes education alone; 2) diabetes education plus food vouchers; 3) diabetes education plus mailed stock boxes; and 4) diabetes education plus combined food vouchers and mailed stock boxes. Each patient will be followed for 12 months, with study assessments at baseline, 3, 6, and 12 months. Primary aim is efficacy of separate and combined interventions on HbA1c at 12 months post-randomization. Secondary aims are efficacy of separate and combined interventions on BP, LDL and QOL as well as cost-effectiveness at 12 months post-randomization.
Description of the LIFT-DM Intervention Group 1 - Diabetes Education Only: Individuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation. Twelve 30-minute weekly sessions will be delivered via the telephone, with two 30-minute booster sessions at months 6 and 9.
Group 2 - Diabetes Education Plus Monthly Food Vouchers: Individuals assigned to this group will receive diabetes education and skills training and monthly food vouchers for use at local farmer's markets mailed to their home. Vouchers for $50 will be mailed monthly for 12 months.
Group 3 - Diabetes Education Plus Monthly Stock Boxes: Individuals assigned to this group will receive diabetes education and skills training and monthly stock boxes with diabetes appropriate food items mailed to their home. Stock boxes with foods valued at $50 will be mailed monthly for 12 months.
Group 4 - Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes: Individuals assigned to this group will receive diabetes education and skills training, monthly food vouchers for use at local farmer's markets mailed to their home, and monthly stock boxes with diabetes appropriate food items mailed to their home. Vouchers for $25 and stock boxes with food valued at $25 will be mailed monthly for 12 months. In essence, the combined group will still receive $50 worth of food supplementation monthly as combination of $25 vouchers and $25 mailed stock boxes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1- Diabetes Education Only | Active comparator | Behavioral: Diabetes Education OnlyIndividuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation. |
| Group 2 - Diabetes Education Plus Monthly Food Vouchers | Experimental | Behavioral: Diabetes Education Plus Monthly Food VouchersIndividuals assigned to this group will receive diabetes education and skills training and monthly food vouchers for use at local Farmer's markets mailed to their home. |
| Group 3 - Diabetes Education Plus Monthly Stock Boxes | Experimental | Behavioral: Diabetes Education Plus Monthly Stock BoxesIndividuals assigned to this group will receive diabetes education and skills training and monthly stock boxes with diabetes appropriate food items mailed to their home. |
| Group 4 -- Diabetes Education Plus Combination of Monthly Food | Experimental | Behavioral: Diabetes Education Plus Combination of Monthly Food Vouchers and Stock BoxesIndividuals assigned to this group will receive diabetes education and skills training, monthly food vouchers for use at local Farmer's markets mailed to their home, and monthly stock boxes with diabetes appropriate food items mailed to their home. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Education Plus Monthly Food VouchersIndividuals assigned to this group will receive diabetes education and skills training and monthly food vouchers for use at local Farmer's markets mailed to their home. | Behavioural | Group 2 - Diabetes Education Plus Monthly Food Vouchers |
| Diabetes Education Plus Combination of Monthly Food Vouchers and Stock BoxesIndividuals assigned to this group will receive diabetes education and skills training, monthly food vouchers for use at local Farmer's markets mailed to their home, and monthly stock boxes with diabetes appropriate food items mailed to their home. | Behavioural | Group 4 -- Diabetes Education Plus Combination of Monthly Food |
| Diabetes Education OnlyIndividuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation. | Behavioural | Group 1- Diabetes Education Only |
| Diabetes Education Plus Monthly Stock BoxesIndividuals assigned to this group will receive diabetes education and skills training and monthly stock boxes with diabetes appropriate food items mailed to their home. | Behavioural | Group 3 - Diabetes Education Plus Monthly Stock Boxes |
Primary outcome
Glycemic control (HbA1c)
Time frame: 12-months post randomization
Blood specimens (10cc of blood) will be obtained by trained phlebotomists or nurse for HbA1c.
3 secondary outcomes
Quality of Life as measured by the SF-12
Time frame: 12-months post randomization
LDL-Cholesterol
Time frame: 12-months post randomization
Blood Pressure
Time frame: 12-months post randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 33166622Walker RJ, Knapp RG, Dismuke-Greer CE, Walker RE, Ozieh MN, Egede LE. Lowering the impact of food insecurity in African American adults with type 2 diabetes mellitus (LIFT-DM) - Study protocol for a randomized controlled trial. Contemp Clin Trials. 2020 Dec;99:106206. doi: 10.1016/j.cct.2020.106206. Epub 2020 Nov 7.
- Protocol paperLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard E Egede, MD principal investigator
State University of New York at Buffalo
Rebekah J Walker, PhD principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Education Plus Monthly Food Vouchers, Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes and Diabetes Education Only in people with Type 2 Diabetes, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (HbA1c) (time frame: 12-months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04181424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.